Hyderabad-based Pharmaceutical firm Aurobindo Pharma Ltd has finally got the nod from the U.S. Food and Drug Administration (US FDA) for generic versions of epilepsy drug Levetiracetam.
The company received approvals for Levetiracetam tablets in 250 milligrams, 500 mg, 750 mg and 1,000 mg doses and an oral solution in 100 mg per milliliter dose.
These drugs are the generic equivalent of UCB Inc.’s Keppra tablets and Keppra oral solution, which together had a market worth about $1.15 billion in the 12 months ended June 2008.
Levetiracetam Tablets is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.